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Presentation

NeuroSpeed® PTA Balloon Catheter & Credo® Stent for intracranial stenosis

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Concept

NeuroSpeed® PTA Balloon Catheter in combination with Credo® Stent Flexible

• PTA alone with NeuroSpeed® PTA Balloon Catheter • PTA with NeuroSpeed® PTA Balloon Catheter + Stenting with Credo® Stent

through NeuroSpeed PTA Catheter

Gentle • Gentle compliance concept of the balloon catheter • Precise and controllable inflation behavior

• Small delivery system diameter • No exchange maneuver or additional crossing of the lesion needed

• Stent for stabilisation and additional support

Optimized stenosis treamtent

reduced snow plow effect less procedurel steps reduced procedural risks

Safe and accurate inflation

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Procedure:

• Delivery of NeuroSpeed® PTA catheter

• Inflation of NeuroSpeed® PTA catheter

• Deflation of NeuroSpeed® PTA catheter

• Delivery of Credo® Stent through low profile NeuroSpeed PTA Catheter if

necessary

Optimized Procedure

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The NeuroSpeed® PTA Balloon Catheter is indicated for dilatation of a stenosis in the cerebral arteries in order to improve perfusion.

NeuroSpeed® PTA Balloon Catheter

Product Overview

NeuroSpeed® PTA Balloon Catheter

Balloon diameter 2.0 / 2.5 / 3.0 / 3.5 and 4.0 mm

Balloon working length 8 mm

Inner diameter 0,0165‘‘

Outer diameter (dist./ prox.) 2.7 F / 3.7 F

Usable length 150 cm

Tip length 10 mm

Tip markers / Balloon markers 1 / 2

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Product Overview – Radiopaque Marker

NeuroSpeed® PTA Balloon Catheter

Two radiopaque markers indicating the nominal length of the balloon

One radiopaque marker indicating the distal tip of the catheter ( For positioning control)

Longer soft tip for improved trackability

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Product Overview

NeuroSpeed® PTA Balloon Catheter

NeuroSpeed® (4.0 x 8 mm)

Diameter

Pressure Dogbone

(max.)

nominal

4 bar 3.40 3.72

6 bar 3.60 4.00

8 bar 3.80 4.23

10 bar 3.90 4.37

• Adjustable diameter over pressure range but NO Dogbone Effect

• Less sizes needed for comparable performance Inflation

Pressure

Balloon Diameter

(mm)

bar psi 2.00 2.50 3.00 3.50 4.00

1.0 14.5 1.66 1.93 2.18 2.97 2.92

2.0 29.0 1.72 2.09 2.42 3.06 3.26

3.0 43.5 1.78 2.22 2.62 3.17 3.50

4.0 58.0 1.84 2.33 2.78 3.25 3.72

5.0 72.5 1.92 2.42 2.89 3.39 3.87

6.0 87.0 2.00 2.50 3.00 3.50 4.00

7.0 101.5 2.10 2.59 3.14 3.62 4.14

8.0 116.0 2.16 2.65 3.22 3.69 4.23

9.0 130.5 2.22 2.70 3.29 3.76 4.30

10.0 145.0 2.27 2.75 3.38 3.83 4.37

11.0 159.5 2.33 2.82 3.46 3.90 4.45

12.0 174.0 2.39 2.87 3.54 3.97* 4.53*

13.0 188.5 2.46 2.92 3.64 4.04 4.62

14.0 203.0 2.52* 2.98* 3.73* 4.11 4.70

NeuroSpeed® Compliance Chart

Nominal Pressure * Rated Burst Pressure

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Credo® Stent

Used in combination with the NeuroSpeed® PTA balloon catheter, the Credo® stent is indicated to increase the vessel diameter of intracranial arteries (for example the ICA, MCA, VA/C4-BA, V4) that are suitable for and accessible to the system (stent with PTA balloon catheter) in patients specific attributes.

Product Overview

Credo® Stent

Stent diameter 3.5 and 4.5 mm

Stent length 15 and 20 mm

Vessel diameter 2.0 – 4.0 mm

Delivery catheter NeuroSpeed® PTA Balloon Catheter

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Credo® Stent

Product Overview

Concept: Gentle stent performance for stabilization of the lesion but no

trauma to surronding pathologic vessel tissue

Potential clinical benefits of a Nitinol self expandable Stent

The higher the compression grade the higher the force it exerts

With higher compression grade, the forces needed to further compress the stent are higher

When further compressed (higher stenosis grade) the stent affects the surrounding tissue with higher intensity

When less compressed (non stenotic section) the stent affects the surrounding tissue with lower intensity

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Credo® Stent

Product Overview – Radiopaque marker concept

Only stent marker are visible (not the whole stent) advantage for follow-up • Barely any

artefacts • Non shadowing

in angiography

3 Distal X-Ray markers Credo® Stent indicating the opening of the device

Distal transport wire marker Credo® Stent indicating the tip of the transport wire for correct placement within the catheter

Central transport wire marker Credo® Stent

indicating the middel of the Stent

Distal radiopaque marker of the NeuroSpeed® PTA balloon catheter for controlled Stent deployment

Distal and proximal radiopaque balloon marker of the NeuroSpeed® PTA balloon catheter indicating the nominal working length of the

balloon

Proximal transport wire marker Credo® Stent

indicating the point up to which the stent can be repositioned

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Procedure

Delivery of low profile NeuroSpeed® and inflation of ballon

i. e. nominal pressure = 6bar

Pathology: symptomatic stenotic lesion

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Procedure

If necessary CREDO® stent deployment after PTA without any exchange maneuver

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Procedure

Delivery of low profile NeuroSpeed® and passage of lesion

Pathology: symptomatic stenotic lesion

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Procedure

Gentle, contrallable Inflation of the NeuroSpeed® PTA catheter

i. e. nominal pressure = 6bar

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Procedure

If necessary CREDO® stent deployment after PTA without any exchange maneuver

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Procedure

If necessary CREDO® stent deployment after deflation without any exchange maneuver

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Treatment Concept

Live presentation of the procedure …